Opportunity to diagnose cancer in March 2020
27. Mr T complains his father was becoming increasingly unwell in 2020 and twice attended hospital because he was vomiting blood. He says the Trust did not adequately investigate his father’s symptoms and missed earlier opportunities to diagnose him with cancer.
28. The Trust has said that due to the incorrect reporting of the biopsy sample in March 2020, it did not diagnose Mr H with cancer at that time. It said it was extremely sorry for this.
29. Mr H’s endoscopy on 5 March 2020 showed he had two large stomach polyps that may have recently bled. This was a new finding compared to the results of the endoscopy he had in 2016. The Trust sent the biopsy samples from the stomach polyps for analysis.
30. BSG guidelines on the management of gastric polyps say samples should be taken from all types of gastric polyps seen during an endoscopy. This is so tests can be done to identify if there are any abnormalities in the tissue. If fundic gland polyps are identified, the BSG guidelines say no further action is needed unless the polyps are causing symptoms.
31. The guidance says there are risks with removing polyps, which include a risk of bleeding requiring further surgery. The decision to carry out a polypectomy should be made in careful clinical consideration of the risks and benefits to the patient.
32. RPATH guidance on tissue pathways for gastrointestinal and pancreatobiliary pathology, sets out how pathologists should analyse and report on specimens to ensure consistency and a high standard of practice. It says fundic gland polyps are one of ‘the commonest types of gastric polyp[s]’. When reporting on a sample, the type of the polyp should be identified and if there are any abnormal cells.
33. Our pathology adviser has explained there can be inaccuracy in the diagnoses made in pathology and while error can happen, the focus should be on keeping this as low as possible.
34. A pathologist at the external reporting service analysed and reported on Mr H’s sample on 12 March 2020. The report says the samples contained fundic gland cysts and showed active inflammation. There was no definite evidence of infection, no cell abnormalities, and no evidence of cancer. Due to the report not identifying anything of concern, the Trust discharged Mr H back to the care of his GP.
35. In terms of the details contained in the report, this meets the standards of reporting set out in RPATH guidance. However, we know from the later internal investigation that the findings reported were not accurate.
36. The expert opinion, obtained in August 2020, confirmed the presence of cancerous cells in the sample and this misdiagnosis was fed back to the external reporting service. The pathologist who first reported on the sample looked at this again and agreed with the expert analysis. The pathologist said they were dismayed and distraught by the error and was unable to say how this had happened. The clinical director also reviewed the sample and agreed this showed cancerous cells.
37. When trying to explain how the error may have occurred, the external reporting service commented that the sample was unusual and had a ‘deceptively bland morphology’. This means that the cells looked uniform in appearance, and this is typically how healthy cells appear.
38. The appearance of the sample being ‘bland’ only partly explains why an error was made. This is because when it was later re-reviewed, all clinicians, including the pathologist who first analysed this, agreed the sample showed abnormalities and cancer was evident. Therefore, this was a case of human error in analysing and reporting on the sample.
39. Due to this error, the Trust did not diagnose Mr H with cancer in March. We consider this was a failing. We are very sorry to hear of the significant effect this error and the delay in diagnosis had on Mr H and his family.
40. If Mr H’s biopsy sample had been accurately analysed and reported on in March 2020, he would have received an earlier cancer diagnosis. It is possible he could have been informed of this diagnosis at the outpatient appointment he attended in March. However, if a second opinion had been necessary, this would have added additional weeks to a diagnosis being determined, as we see happened with the sample taken in July 2020. It is however, likely that he would have been informed of his diagnosis by the end of April 2020. This means there was a five to six month delay in the Trust diagnosing Mr H.
41. Mr T has questioned what difference this delay could have had for the care his father was able to have, or to his long term prognosis. We have considered if this earlier diagnosis could have made a difference to the treatment options available to Mr H.
42. Our gastroenterology adviser notes that by September, a CT scan showed the cancer had already spread extensively in Mr H’s body. He was told at that time that he would not be fit enough to undergo any cancer treatments. It is possible that the spread of the cancer may have been present for a number of months before he was diagnosed.
43. However, even if the cancer had not spread by March or April, it is unlikely Mr H would have been well enough to go through surgery or to have intensive treatment because of his other medical conditions and frailty. On balance, we do not consider an earlier diagnosis would have made a difference to the treatment Mr H could have had, or to his overall chances of survival.
44. An earlier diagnosis would have given Mr H and his family certainty about his condition and why he was so unwell. It would have given them more time to come to terms with the diagnosis, and for Mr H to have discussed his wishes and planned for end of life care. We also recognise that learning of the misdiagnosis caused Mr H and his son to suffer considerable distress.
45. Our Principles for Remedy say that when something has gone wrong that has caused an injustice or hardship, public bodies should act to put things right. Appropriate remedies can include an explanation, apology, and a review of the processes or procedures that led to the error happening.
46. We have looked at the actions the Trust has taken in response to this complaint. It agreed the error in pathology reporting meant it misdiagnosed Mr H in March 2020. It said it was extremely sorry for this and shared the apology from the pathologist who made the mistake. We consider this apology is appropriate in response to what went wrong.
47. Mr T said he does not feel the Trust offered any reassurance that mistakes will not be made again and he feels frustrated that no lessons seemed to have been learnt from this. The Trust’s complaint response does not explain how it investigated what went wrong, or what actions it took to address this.
48. The information the Trust has sent to us shows the actions it took. It told the external reporting service that an error had occurred. The service investigated the cause of this and shared the results with the Trust.
49. The service said there had been no previous errors with the individual pathologist’s work and they checked through the batch of cases the pathologist reported on the same day and found no concerns. It said there may never be a full explanation for what happened and determined this was a single error. It shared a letter from the pathologist which showed they had reflected on the case, accepted they had made a technical error and shared unreserved apologies for this.
50. The Trust documented it was happy the checks it has on the referral laboratories it uses are sufficient, and that the clinicians at the service were qualified to do their work. It noted this had been a difficult case and that mistakes, although rare, can happen. It did not consider any further actions were necessary.
51. From the information provided to us, we are satisfied the Trust took relevant steps to identify the cause of the error and assess if any further action was needed to make sure this did not happen again. When it was determined this was due to human error, it considered the actions taken by the external service and the pathologist who made the mistake. It then reviewed its own processes for outsourcing laboratory work. It did not identify any wider concerns through this.
52. We consider the Trust’s approach to reviewing its processes is in line with Our Principles for Remedy. It considered the actions taken by the external reporting service and was satisfied there was nothing further it needed to do to address this.
53. Following careful consideration of the action the Trust has already taken to address what went wrong, we consider it has offered a suitable apology and it has appropriately reviewed its processes.
54. While we are satisfied the Trust took appropriate steps to investigate what took place, it did not explain this in its complaint response. If it had, this would have given reassurance to Mr H and his son of how seriously it had taken his case, and why it was satisfied the necessary checks and processes were in place. We consider it should now write to Mr T to explain the work it completed.
55. We also consider a financial remedy would be appropriate to fully address the personal impact Mr T has suffered. We partly uphold this part of the complaint and we have set out our recommendations in detail at the end of this report.
Opportunities to diagnose cancer between April and September 2020
56. Mr T questions if, after the error made in his father’s care in March, there were any other missed opportunities for the Trust to diagnose him before September. The Trust has said it did not identify any other missed opportunities to make this diagnosis.
57. Following his attendance to hospital in March, Mr H next attended hospital on 15 July 2020. Clinicians took further samples of his stomach polyps during an endoscopy a few days later. The consultant planned for him to return in four weeks for a polypectomy.
58. Mr H next attended hospital on 27 August 2020. He had an urgent endoscopy and this showed the largest polyp had recently bled. The gastroenterology doctor considered this polyp was the likely cause of his symptoms and surgically removed it. Mr H was discharged on 30 August while the team waited for the outcome of the pathology results.
59. Our gastroenterology adviser has said the clinical team appropriately arranged endoscopies and took biopsies of the stomach polyps during Mr H’s July and August attendances. These actions are in line with the BSG guidance for the management of gastric polyps, referred to above.
60. After being incorrectly diagnosed in March 2020, the next opportunity for the Trust to investigate and diagnose Mr H was in July. It took a longer period of time for the results of the July biopsy to be reported because the unusual findings required a second opinion.
61. The sample was first analysed by the Trust’s pathology team on 3 August. When they were unable to reach agreement on a diagnosis, this was sent to the expert pathologist and their opinion was sent back to the Trust on 27 August. The results were discussed by a multidisciplinary team on 2 September, before Mr H was told about his diagnosis at a clinic on 9 September.
62. We note that the expert opinion was received by the Trust while Mr H was an inpatient, however we appreciate the clinical team needed to first review the report and decide the next steps for his care before discussing this with him. Once this took place, the consultant arranged to speak with Mr H within seven days.
63. The Trust’s patient information leaflet for gastroscopies says, following the procedure, it will normally take seven to ten days for the laboratory to report the results. However, this is not a fixed timescale and there are no national guidelines for how long results should take.
64. The NHS website says the time it takes for biopsy results to be returned can be difficult to predict because sometimes more tests are needed after the first examination of the sample, and it can be necessary for the sample to be sent for a specialist opinion. Following a gastroscopy, it says biopsy results can take up to two months.
65. There is no indication there was any avoidable delay in the process of the Trust confirming the pathology results in July and August. This is because the expert opinion was necessary so the Trust could make an accurate diagnosis. We can see the timescale of nearly six weeks for the diagnosis to be confirmed falls within the timescale outlined by the NHS website for gastroscopy results.
66. Following careful consideration of the events from March to September 2020, there was a missed opportunity to diagnose Mr H with cancer in March. In reviewing the care he received in the following months, we have not identified any further missed opportunities for the Trust to make an earlier diagnosis. We hope the explanations provided in this report will reassure Mr T on why we do not have concern with the remaining period of care.
Delay in arranging a polypectomy
67. Mr T is unhappy the Trust should have arranged for his father to have a polypectomy four weeks after his discharge in July, but this did not happen. He says the Trust should have acted more promptly to remove his father’s polyps.
68. The Trust has said the COVID-19 pandemic caused the significant shutdown of endoscopy activity in 2020. It also said the large size of Mr H’s polyp meant that a limited number of endoscopists could carry out the procedure, and this further added to the waiting time.
69. Our Principles of Good Administration say that to be customer focused, public bodies should, ‘do what they say they are going to do’.
70. Guidance from the BSG, ‘advice for endoscopy teams during Covid-19’ published on 3 April 2020 recommended that ‘all endoscopy except emergency and essential procedures should stop immediately’. Five weeks after this pause, the BSG issued ‘endoscopy early recovery guidance’ setting out how services should restart. It said the reintroduction of services should be phased and planned. It noted that extra time would be needed to prepare spaces for procedures due to increased infection control.
71. On 26 August, the BSG said that endoscopy services had recovered to 40-50% of pre-COVID-19 levels. It said there was a considerable backlog of patients waiting for services due to the interruption to services over the past few months.
72. Mr H was discharged on 20 July with a plan for him to return in four weeks for a polypectomy. The records show that when this was arranged, it was booked for 4 September. This date was six weeks and four days after his discharge. If the polypectomy had been arranged within the planned four week timescale, Mr H would have had this procedure by 17 August.
73. In terms of the timescale agreed for the polypectomy, our gastroenterology adviser has explained that the endoscopy report from 17 July supports the removal of the polyps was clinically urgent. This is because some of the polyps were large, and the recent bleeding had led to Mr H requiring hospital treatment.
74. While Mr H’s case was clinically urgent, we have to also carefully consider the national clinical picture at the time of events. The measures put in place in response to the COVID-19 pandemic put pressure on endoscopy services as they were trying to manage the backlog of cases that had grown due to the initial restriction on patients being treated. Procedures were also taking longer due to the extra cleaning necessary between each patient.
75. Our gastroenterology adviser has confirmed that polypectomies are specialist procedures that take time and are performed by a limited number of trained senior endoscopists.
76. If the Trust had wanted to avoid any delay in the polypectomy going ahead, it could have considered referring Mr H to a different hospital where there may, or may not, have been an earlier available slot. However, this approach may not have made any significant difference to the time taken for this to go ahead, or have resulted in a better outcome. It also may not have been suitable for Mr H if it meant travelling further away for treatment.
77. The reasons the Trust has said the polypectomy took longer to arrange than planned reflect the challenging national picture faced by NHS endoscopy services at that time. While alternative action could have been considered by the Trust to try and avoid any delay, we do not consider this would have necessarily benefited or been suitable for Mr H.
78. We are very sorry to hear of how Mr H suffered with his symptoms in August and that when he attended on 27 August, he required an urgent procedure to remove the bleeding polyp.
79. In careful consideration of the circumstances the Trust faced at that time, we accept these challenges affected how quickly it could arrange Mr H’s treatment. For this reason, we do not uphold this part of the complaint.
Complaint handling
80. Mr T complains the Trust’s complaint response was not detailed and did not clearly explain what had happened. This left him and his father with a lot of questions. He says his father was scared and the complaint response showed little empathy, and did not offer any reassurances that lessons had been learnt from his case.
81. We are sorry to hear of the distress Mr T describes he and his father suffering after receiving the complaint response from the Trust. We acknowledge the complaints process can be difficult to go through.
82. The Ombudsman’s Principles of Good Complaint Handling say organisations should be: ‘open and honest when accounting for their decisions and actions. They should give clear, evidence-based explanations, and reasons for their decisions. When things have gone wrong, public bodies should explain fully and say what they will do to put matters right as quickly as possible’.
83. The Trust’s complaint response, dated 20 November 2020, is based around two key parts of Mr H’s complaint: a query if there were opportunities from 2013 onwards to earlier diagnose cancer, and concerns about what happened from February 2020 onwards.
84. In response to the query about the care provided from 2013 onwards, the Trust said it had reviewed Mr H’s biopsies taken in 2013 and 2015 and confirmed the samples did not show evidence of cancer. It said he had been given the correct treatment during those years.
85. In response to the question of the care provided in 2020, the Trust explained what happened when the biopsy samples were taken in March and July 2020. It confirmed there was a missed opportunity to diagnose Mr H’s cancer in March and said it was extremely sorry for this.
86. The Trust’s response is concise and we can see it focused on confirming the outcomes of the review by its clinicians of Mr H’s care dating back to 2013. We do appreciate Mr H wanted a more detailed explanation of what took place.
87. Following careful consideration of the content of the letter, we consider the Trust responded to the issues Mr H raised and explained the basis of its decisions. Where it found error, it accepted that something had gone wrong. This was completed in line with Our Principles for Good Complaint Handling.
88. As noted above, however, the Trust did not then explain the work it did to understand what caused the error and if this led to any changes in its processes. We understand Mr H and his son were upset and angry about what had happened. Not being given any reassurance of the steps the Trust had taken to assure itself of its processes contributed to their distress and frustration.
89. We do not consider the Trust went far enough to explain what it did in response to Mr H’s case and this was a failing in complaint handling.
90. In terms of the complaint response showing understanding and empathy for Mr H and what he had been through, we consider the Trust gave a suitable apology for the error in his care. However, we note that at the end of the letter, it says it hoped Mr H’s treatment was ‘progressing smoothly and improving [his] health’.
91. Our Principles of Good Complaint Handling say public bodies should ‘treat complainants sensitively and in a way that takes account of their needs’. They should ‘communicate with the complainant in a way that is appropriate to them and their circumstances’ and take into account the ‘seriousness of the issues raised [and] the effect on the complainant…’.
92. Two months before Mr H received this letter, he had been told he was not well enough for cancer treatment and he and his family should be considering his end of life care. While we appreciate the Trust likely intended to send well wishes to Mr H, its comment that it hoped his health was improving was not appropriate for his circumstances.
93. We can understand why this comment made Mr H and his son feel that the Trust’s response was not sensitive or personal to his case. This does not comply with Our Principles of Good Complaint Handling and we consider this was a failing.
94. While we can see the Trust responded concisely to Mr H’s complaint, we do not consider it went far enough to explain what work it did to investigate the error in his care. We also do not consider the response demonstrated sensitivity to Mr H’s circumstances. For these reasons, we partly uphold this complaint and we have set out our recommendations below.